Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077375
• Other study ID #: MLN-MD-28
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2010
• Last updated: December 21, 2011
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: December 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Description:

• Two weeks Duloxetine 60 mg Open-Label Period

• Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)

• One week Double-Blind Down-Taper Period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of fibromyalgia

• Have been treated with a stable dosage of duloxetine (60 mg/day) for = 4 weeks immediately before Screening (Visit 1)

• Duloxetine must have been prescribed for the treatment of Fibromyalgia

• Have a VAS 1-week pain recall score = 40 mm and = 90 mm

• At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score = 40 mm and be dissatisfied with current Duloxetine treatment.

Exclusion Criteria:

• Suicidal risk

• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder

• Myocardial infarction and/or stroke within the prior 6 months

• Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)

• Substance abuse

• Pulmonary dysfunction

• Severe renal impairment

• Active cardiac disease

• Liver disease

• Uncontrolled narrow-angle glaucoma

• Autoimmune disease

• Cancer

• Inflammatory bowel disease

• Unstable endocrine disease

• Prostatic enlargement

• Female patients who are pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Placebo
Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
• Milnacipran
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper. Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Locations

Country	Name	City	State
United States	Forest Investigative Site 006	Atlanta	Georgia
United States	Forest Investigative Site 024	Atlanta	Georgia
United States	Forest Investigative Site 017	Bellevue	Washington
United States	Forest Investigative Site 023	Charlotte	North Carolina
United States	Forest Investigative Site 002	Cincinnati	Ohio
United States	Forest Investigative Site 003	Cleveland	Ohio
United States	Forest Investigative Site 022	Cromwell	Connecticut
United States	Forest Investigative Site 021	Danbury	Connecticut
United States	Forest Investigative Site 007	Delray Beach	Florida
United States	Forest Investigative Site 015	Evansville	Indiana
United States	Forest Investigative Site 011	Greer	South Carolina
United States	Forest Investigative Site 010	Jackson	Mississippi
United States	Forest Investigative Site 020	Mechanicsburg	Pennsylvania
United States	Forest Investigative Site 001	Medford	Oregon
United States	Forest Investigative Site 008	Ocala	Florida
United States	Forest Investigative Site 009	Orlando	Florida
United States	Forest Investigative Site 016	Orlando	Florida
United States	Forest Investigative Site 026	Racine	Wisconsin
United States	Forest Investigative Site 013	Sacramento	California
United States	Forest Investigative Site 004	Salt Lake City	Utah
United States	Forest Investigative Site 025	St. Louis	Missouri
United States	Forest Investigative Site 012	St. Petersburg	Florida
United States	Forest Investigative Site 014	Syracuse	New York
United States	Forest Investigative Site 019	Tampa	Florida
United States	Forest Investigative Site 018	Willingboro	New Jersey
United States	Forest Investigative Site 005	Worchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Cypress Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)	The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.	Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.	No
Secondary	Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score	The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).	Change from Baseline (Week 3) to Visit 5 (Week 13)	No